Patent Application
20200179300
This invention relates to the field of medicine and wound care and more specifically to a Pharmaceutical Composition that when applied to a topical ulcer, and more specifically to a decubitus ulcer, a cancerous skin lesion, a topical breast abrasion, and other topical irritations, will provide accelerated curing and healing of such conditions.
The human body is covered with skin, the skin is a part of the integumentary system. The skin: waterproofs the body and prevents fluid loss; if unbroken blocks the penetration of pathogens into the body; is a receptor for the sense of touch; synthesizes vitamin D for the body; and protects the body from ultraviolet radiation.
There are a variety of lesions that occur on and in the skin. Some of those lesions which this application addresses are:
We are two practicing pharmacists and a pharmaceutical manufacturer of ointments and creams. In our practices we all have known and treated many patients with topical skin conditions and observed the healing rates for such conditions. We know first-hand that certain skin conditions never heal or heal incompletely over long periods of time. We have personally observed skin cancer lesions on the face, scalp, arms, legs which we believed to be squamous cell carcinoma or basal cell carcinoma. In these patients it appeared that the lesion would not heal, would bleed and appear to continue growing.
Observed also and after discussions with patients, caregivers and patient's relatives, it was discovered that a certain formulation consisting of an active pharmaceutical ingredient together with a specific base formulation promoted curing or accelerated healing of a variety of conditions. This formulation was examined for its superior effectiveness leading to the discovery found within this patent application.
Knowing that much of the effectiveness of this invention relies on its ability to demonstrate antimicrobial effectiveness, samples of the formulation were provided to an independent laboratory and ANTIMICROBIAL EFFECTIVENESS TESTING USP 40, NF 35<51>. The SUMMARY of the Study (#39412, Log #606718) states: “The preservative system utilized in the product tested should be evaluated according to the Criteria for Antimicrobial Effectiveness for Category 1-4 Products, USP 40, NP35, <51>, Antimicrobial Effectiveness Testing. Based on the Antimicrobial Effectiveness Test results, the product would PASS meeting the requirements for a Category 1 Preserved System. Based on the CFTA guidelines this product is considered well preserved.”
Such a formulation will have a drastic reduction on healthcare costs because the topical application of this formulation will effect cure or accelerated healing resulting in no need for costly operations, hospitalizations, or long-term treatment.
The features of the invention believed to be novel and the elements characteristic of the invention are set forth with particularity in the following cases.
A 76 year old male with senile dementia suffered from a decubitus ulcer about 2.5 cm in diameter not reaching the bone but with broken skin. The patient was bedridden and rotated periodically by caregivers but the bedsore still took hold and grew on his right buttock. He was treated with a mixture of Thymol Iodide in a Petrolatum, Zinc Oxide, Olive Oil and Lanolin Base.
Healing started at the peripheral portion of the ulcer within 48 hours with complete resolution of the ulcer within 7 days.
A >45 year old female developed a 10 cm×10 cm skin abrasion under her left breast due to the breast rubbing against her chest wall under the breast. The skin was red, chafed, open, oozing and bleeding. The patient had tried nystatln ointment, triple antibiotic ointment, and hydrocortisone 1% cream all for 5 day periods of time each without any success. She was supplied with a mixture of Thymol Iodide in a Petrolatum, Zinc Oxide, Olive Oil and Lanolin Base and told to apply the mixture twice a day.
Healing started over the entire 10 cm×10 cm within 24 hours. The abrasion was completely healed within 5 days.
A 70 year old male presented with a 3 mm Basal Cell Carcinoma lesion on his forehead. The lesion had been previously identified and treated by his dermatologist. He indicated that the lesion reappeared shortly after cryosurgery by the dermatologist and continued to peal repeatedly and bleed. The patient applied a mixture of Thymol Iodide in a Petrolatum, Zinc Oxide, Olive Oil and Lanolin Base to the lesion twice daily. Complete resolution occurred within 96 hours.
A 70 year old male presented with a 3.5 cm diameter Basal Cell Carcinoma lesion on his right leg. The lesion had been previously identified and treated by his dermatologist. He indicated that the lesion reappeared shortly after cryosurgery by the dermatologist and continued to peal repeatedly. The patient applied a mixture of Thymol Iodide in a Petrolatum, Zinc Oxide, Olive Oil and Lanolin Base to the lesion twice daily. Complete resolution occurred within 7 days.
A 70 year old female with senile dementia suffered from a decubitus ulcer about 2 cm in diameter not reaching the bone but with broken skin. The patient was bedridden. She was treated with a mixture of Thymol Iodide in a Petrolatum, Zinc Oxide, Olive Oil and Lanolin Base.
Healing started at the peripheral portion of the ulcer within 48 hours with complete resolution of the ulcer within 7 days.
A 2 year old male bit into a live electrical line and the electric burned away a 2.5 cm diameter section of his lip on the left side of his face. Treatment was with a mixture of three antibiotics in a petrolatum base ointment with additives consisting of: a fatty acid fuel source for acetyl coenzyme A generation and an antioxidant. It is believed that antibiotics kept the skin from getting infected and the petrolatum with additives accelerated and increased the skin growth. All said, the skin began to grow too quickly and it was necessary to construct a prosthesis which hooked into the lip area of the re-growing burned skin site, and was held in place by a second part of the prosthesis wrapped around the ear. This device was needed for about 6 months to hold the accelerated skin growth from forming too small a lip.
A 70 year old female presented with a 1.3 cm Basal Cell Carcinoma lesion on her scalp. The lesion had been previously identified and not yet treated. At this time the lesion was beginning to bleed in its central part. The patient applied a mixture of Thymol Iodide in a Petrolatum, Zinc Oxide, Olive Oil and Lanolin Base to the lesion twice daily. Healing started within 48 hours and noticeable resolution was observed at 7 days. Complete resolution took about 21 days.
This invention will now be described in detail.
The pharmaceutical topical preparation may be in an ointment, cream, gel, liquid, emulsion, semi-solid, or other form that permits contact with the surface of the skin. It may also be used on, within, or on top of a bandage, device or dressing. This invention consists of the following ingredients for the purposes so presented:
